The present invention generally relates to packaging for medical devices, especially to packaging which includes a flexible tip tray for temporarily supporting a curved tip portion of a medical catheter. More particularly, the invention relates to sterilizable packaging for medical catheters, which packaging includes a flexible tip tray made of a material having a hardness value which is less than that of the elongated medical catheter packaged thereby The flexible tip tray includes a flexible groove having a curved plan configuration corresponding to the shape of the curved tip portion of the medical catheter and having a cross-section including a circular portion for encircling the medical catheter. The flexible tip tray rests upon an elongated mounting card positioned within an enclosed elongated pouch. The walls of the flexible groove of the flexible tip tray readily expand and contract so as to accommodate catheters of differing French sizes while allowing for sliding removal of the catheter tip portion therefrom without damaging or deforming the curved catheter tip portion
Certain catheters include tip portions having curved configurations which are designed for facilitating passage of the catheter into and through body passageways such as the lumen of a blood vessel, a heart passageway, and the like, often with fluoroscopic guidance. Surgeons and medical teams have come to rely upon catheter tip portions having specially designed shapes, and it is important that these shapes be maintained to close tolerances after manufacturing and sterilization has been completed. This includes maintaining the shape during transport and storage such as by providing a tip tray which is intended to protect and maintain the curve of the tip portion of the medical catheter. It is also important that the curved tip configuration be maintained without damage to the catheter not only during transport and storage but also when the curved tip portion is removed from the tip tray just prior to implementation of a medical procedure such as angioplasty.
Medical catheters must exhibit adequate flexibility so that the tubing thereof can easily wind its way through body passageways which include bends and the like whereby the catheter can traverse a pathway through, for example, branching blood vessels and curved pathways within and into blood vessels, body cavities, organs and the like. Furthermore, in many instances, a catheter is manipulated from a proximal location outside of the body in order to position the distal portion of it in the vicinity of the administration or treatment location. In such systems or assemblies, it is important that the catheter exhibit adequate torque control so that it can be manipulated through narrow and branching passageways by radial movements and the like while having enough longitudinal or column resistance to negotiate through these passageways. This being the case, it is important that the catheter be made of a material meeting certain flexibility and stiffness characteristics at the same time. Particularly suitable in this regard are certain polyurethane materials that are especially advantageous for many uses, particularly with respect to catheters for angioplasty treatments. An ideal tip tray packaging component should be able to perform the necessary shaping and protecting function without damaging materials such as the polyurethanes that are well-suited for angioplasty catheters and the like. Accordingly, it is important that tip trays do not cause any damage to the curved tip portion of the catheter, either during insertion into, storage within, or removal from the tip tray.
Besides concerns regarding prevention of damage to the curved catheter tip portion, tip trays can interfere with easy and rapid removal of the catheter from the packaging therefor. Often, the tip tray slides out of the pouch-like packaging together with the catheter. This requires a member of the medical team to separately handle and dispose of the tip tray itself, as well as the rest of the packaging for the catheter. Accordingly, it would be advantageous to provide a catheter packaging assembly which includes a tip tray that remains within the packaging pouch even upon removal of the curved tip catheter from the pouch and from the tip tray within the pouch.
The present invention provides packaging for medical catheters which incorporates a flexible tip tray that forms the curved tip portion of a catheter while being able to accommodate catheters of different French sizes. The flexible tip tray also has a hardness value less than and a flexibility greater than that of the curved catheter tip portion, which is contrary to prior art tip trays made of generally rigid and substantially inflexible material. The flexible tip tray is a component of a packaging assembly including an elongated pouch and an elongated mounting card positioned within the enclosed elongated pouch. The flexible tip tray rests upon the elongated mounting card within the elongated enclosed pouch. When the curved tip catheter is removed from the pouch, the curved tip slidingly passes through the curved groove of the flexible tip tray. Due in large measure to the flexibility of the flexible tip tray, the tray maintains interference engagement with other components of the packaging and is retained within the pouch even while the curved tip portion of the catheter slides along and through the curved groove of the flexible tip tray when the medical team member pulls the catheter out of the pouch.
It is accordingly a general object of the present invention to provide improved packaging for medical catheters that includes a flexible tip tray component.
Another object of the present invention is to provide an improved flexible tip tray that accommodates catheters of differing French sizes without in any way damaging the catheters.
Another object of this invention is to provide an improved catheter packaging assembly that minimizes the chance of developing ovality characteristics within the curved catheter tip portion.
Another object of the invention is to provide an improved tip tray packaging component molded within a master mold having a groove with a precise elongated curve and configuration and a cross-section shape which accommodates multiple French sizes.
These and other objects, features and advantages of the invention will be clearly understood through a consideration of the following detailed description.